Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia
| Tracking Information | |||||
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| First Received Date ICMJE | January 10, 2011 | ||||
| Last Updated Date | January 10, 2011 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
intraocular pressure [ Time Frame: at 2 minutes after intubation ] [ Designated as safety issue: Yes ] determining intraocular pressure in atracurium and cisatracurium groups |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
systolic blood pressure [ Time Frame: at 2 minutes after intubation ] [ Designated as safety issue: Yes ] identification of systolic blood pressure in atracurium and cisatracurium groups |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia | ||||
| Official Title ICMJE | Study of Effects of Cisatracurium and Atracurium on Intraocular Pressure | ||||
| Brief Summary | The purpose of this study is to determine which drug makes lower intraocular pressure |
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| Detailed Description | Increase in intraocular pressure (IOP) following tracheal intubation during general anesthesia can be troublesome. The investigators compared the influence of cisatracurium and atracurium on IOP in patients undergoing general anesthesia. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
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| Condition ICMJE | Intraocular Pressure | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 90 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: ASA class of I or II baseline IOP of lower than 20 mmHg stable hemodynamics no history of ophthalmic diseases not using drugs affecting IOP (e.g. anticholinergics, sympathomimetics) no contraindication for atracurium or cisatracurium administration. Exclusion Criteria: difficulty in mask ventilation or in tracheal intubation end expiratory CO2 of below 35 mmHg or over 45 mmHg O2 saturation of below 90% |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01273831 | ||||
| Other Study ID Numbers ICMJE | ASD-1213-10 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences | ||||
| Study Sponsor ICMJE | Isfahan University of Medical Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Isfahan University of Medical Sciences | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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